Assessment of Correlation Between Changes of Shear Wave Elastography and Surface Electromyogram of the Masseter

Not Applicable

Completed

• Conditions: Masseter Muscle Spasm
• Interventions: Device: Ultrasound exam by Supersonic Shear Imaging® technique; Device: EMG examination by electromyograph Keypoint system

• Registration Number: NCT02425839
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

Diagnoses and follow up of muscles diseases lack imaging. Severity assessment of masticatory dysfunction and follow up of treatment effectiveness is currently based only on clinical features. Supersonic ShearWave Imaging® is a new, non-invasive, non-irradiating and dynamic imaging technique that uses ultrasound and allows shear wave elastic modulus in a muscle in order to study its viscoelastic properties.

In this study, the investigators study the correlation between changes of shear wave elastography modulus and surface electromyogram features of the masseters between rest and maximal voluntary contraction.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-09
• Study First Submitted QC: 2015-04-21
• Study First Posted: 2015-04-24
• Study Start: 2015-05
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-05
• Last Update Posted: 2015-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• People with social security.
• People aged 20 to 40 years, of both sexes.
• People that gave and signed consent to participate in the study.

Exclusion Criteria

• Any concomitant muscle disease (myopathy, myositis...)
• Botulinum toxin injections in the masseter in the last 3 months preceding the study.
• Any treatment that induces muscular effect (baclofen, benzodiazepine)
• Bruxism or any masticatory apparatus disease
• Any surgery of the masticatory apparatus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental group	Ultrasound exam by Supersonic Shear Imaging® technique	* ultrasound exam by Supersonic Shear Imaging® technique * EMG examination by electromyograph Keypoint system.
Experimental group	EMG examination by electromyograph Keypoint system	* ultrasound exam by Supersonic Shear Imaging® technique * EMG examination by electromyograph Keypoint system.

Primary Outcome Measures

Name	Time	Method
Elastic modulus using Supersonic Shear Imaging® technique on superficial and deep masseter parts at rest and maximal voluntary contraction.	Day 1 (inclusion day)

Secondary Outcome Measures

Name	Time	Method
Thickness of the masseter deep part mesured by Supersonic Shear Imaging® technique	Day 1 (inclusion day)
Thickness of the whole masseter mesured by Supersonic Shear Imaging® technique	Day 1 (inclusion day)
Thickness of the masseter superficial part mesured by Supersonic Shear Imaging® technique	Day 1 (inclusion day)

Trial Locations

Locations (1)

CHU de Saint-Etienne; 🇫🇷 Saint-Etienne, France